Nutrition Educational Programme Impact on Serum Phosphate Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Reduction of PhosphateSerum Level
Study Overview
Brief Summary
Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels > 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric, clinical, demographic and laboratory parameters (serum phosphorus concentration will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention.
Detailed Description
Background: In Chronic Kidney Disease patients, it is crucial to begin treatment as soon as possible in order to minimize the complication-related risks. Encouraging patients to adhere to their treatment plans is a great challenge for health care professionals. Objectives: The aim of this study is to evaluate the impact of a nutrition educational programme on the hyperphosphatemia using the transtheoretical model of eating behavior. Subjects and Methods: A prospective Interventional study is being conducted in a dialysis centre with 180 stage 5D Chronic Kidney Disease patients who exhibit phosphate serum levels > 5.5 mg/dL. The educational intervention consists of lectures and group dynamics sessions performed during dialysis sessions. Anthropometric (weight, height, body mass index), clinical, demographic (sex, age, time on dialysis programme, literacy/schooling) and laboratory parameters (phosphate serum levels) will be evaluated and the transtheoretical model of eating behavior (TMFB) will be applied pre- and post-intervention. Reduction of phosphate serum levels and positive/negative behavioral changes will be the evaluated outcomes. Statistical Analyses will be carried out in order to compare the effect of educational programme on phosphate serum levels and on the behaviour changes.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who freely consent to participate in this study
- •aged from 18 years or older
- •both genders
- •phosphate serum levels higher than 5.5 mg/dl (last 3 consecutive monthly measures)
Exclusion Criteria
- •patients who do not consent to participate in this study
- •cognitive deficit
- •mental diseases
- •patients whose phosphate serum levels lower than 5.5 mg/dl or equal to 5.5 mg/dl
Arms & Interventions
Educational Programme Group
Stage 5D Chronic Kidney Disease Patients on high-efficiency hemodialysis programme - 4-hour sessions, 3 times a week will be followed up
Intervention: Educational Programme (Other)
Outcomes
Primary Outcomes
Reduction of PhosphateSerum Level
Time Frame: 3 months
Phosphate Serum Levels above or equal 5.5 mg/dl will be monitored in order to identify reduction
Secondary Outcomes
- Positive or Negative Behavioral Change According to the Transtheoretical Model of Eating Behavior(3 months)
Investigators
Marcus Vinicius de Souza Joao Luiz
MSC., Pharm.D.
University of Sao Paulo